1. Field of the Invention
The present invention pertains to the field of topical ointments and, more particularly, to products that are used for the treatment of superficial lesions including skin tears. Still more specifically, the medicament includes a carrier component, an emollient component, a cosmetic biocide component, and a mild keratolytic component that will facilitate effective wound site reepithelialization.
2. Description of the Prior Art
Superficial skin injury and skin tears may result in painful and unpleasant lesions that may progress to infection, continued wound deterioration and wound chronicity. Infections are known to be associated with rapid wound deterioration. Exposed, desiccated, and injured tissue may be slow or recalcitrant to healing, particularly in the elderly or medically compromised population.
Skin tears frequently occur in bedridden, medically compromised and institutionalized persons. Healing is frequently delayed and complicated by medical problems, the patient's low-level ambulatory status, and the availability of efficacious treatment modalities. In bedridden and institutionalized persons, tissue damage commonly induces a painful lesion that rapidly desiccates or becomes infected. Factors that may delay healing include, but are not limited to the following items: (1) poor circulation; (2) decreased elastin and collagen production in the skin (i.e., decreased cellular activity associated with healing); (3) bacterial contamination; (4) medications; and (5) extrinsic environmental factors (e.g., shear, pressure, and incontinence).
Current treatment modalities consist of applications of various types of gauze, adhesive synthetic dressings, and antimicrobial ointments. These products are only marginally effective. Furthermore, no products are available which are designed solely and specifically for skin tear injuries.
The U.S. Food and Drug Administration has approved guidelines for the use of cosmetic chemicals that are commonly provided in over-the-counter ointments. These chemicals are submitted to the FDA for over the counter drug review and approval. Approval is indicated by a final publication or report in the form of a monograph. The Cosmetic Ingredient Review, Ingredient Publication Status (Jun. 24, 1994) from the Cosmetic & Toiletry Foundation Association in Washington, D.C. provides a list of approved cosmetic chemicals, which is hereby incorporated by reference herein. This publication provides a list of approved cosmetic ingredients, the approved functions for these ingredients, and citations to the corresponding monograph publications for each ingredient. These "cosmetic" ingredients can be used in wound-care products, as well as other products such as lotion, hair dye and the like. The general nature and function is known for each ingredient, but great variations in efficacy can be observed based upon the precise selection of ingredients and the concentration of ingredients. Even within the approved concentration ranges, many of these approved chemicals are known to induce adverse reactions in sensitive patients.
U.S. Pat. No. 5,266,318, issued to Taylor-McCord, teaches the use of an anthraquinone-free cold processed fresh aloe vera extract for treatment of wounds to the skin. Aloe vera gel is described as a mucilaginous jelly from the parenchymal cells of the aloe plant. This jelly includes about 98.5% water with about 60% of the total solid being made up of polysaccharides, and the balance including organic acids and inorganic compounds. It is noted that a present controversy exists over the precise curative agent that is found in aloe vera, but the gel is generally acknowledged to have an ability to reduce swelling and irritation. This therapeutic benefit may be partially offset by cytotoxic activity of the yellow sap and aloin portions of the gel.
U.S. Pat. No. 5,110,593, issued to Benford, describes a topical ointment for use in treating diaper dermatitis. An antimicrobial agent consisting of 0.22% 8-hydroxyquinoline is combined with petrolatum, lanolin, beeswax, sodium borate, lanolin alcohols, methyl salicylate, sorbitan sesquioliate, methylparaben, propylparaben, and trisodium HESTA. This substance is free of keratolytic ingredients such as allantoin and urea.
There remains a need for a non-irritating, topical ointment or medicament that is specifically designed to promote the reepithelialization of skin tears.